DRUG
Decapeptyl® SR 22.5mg
22.5mg, intramuscular injection, given on day 1 / month 0 \& month 6 (+/- 7 days).
Status
Terminated
Phase
Phase 4
Enrollment
27
Locations
35
Results
Posted
Publications
0
Study summary
The purpose of this study is to demonstrate that treatment with a 6-monthly injection of hormone therapy is as good and as well tolerated as the standard 3-monthly hormone therapy injections available for treating prostate cancer. The study will also aim to answer whether both doctors and patients would prefer treatment with a 6-monthly injection rather than injections every 3 months.
Interventions
DRUG
22.5mg, intramuscular injection, given on day 1 / month 0 \& month 6 (+/- 7 days).
DRUG
For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall
Timeline
First posted
Aug 28, 2012
Study start
Aug 2012
Primary completion
Feb 2014
Study completion
Feb 2014
Results posted
Sep 29, 2015
Registry updated
May 23, 2025
Outcomes
Percentage of Participants Maintaining Biochemical Castration
Time frame · 6 months
Patients with serum total testosterone (STT) level lower than 0.5 ng/mL after 6 months of treatment.
Percentage of Participants Maintaining Biochemical Castration After 12 Months of Treatment.
Time frame · 12 months
Patients with serum total testosterone (STT) level lower than 0.5 ng/mL, 12 months after randomisation..
Percentage of Participants Demonstrating Stable Prostate-specific Antigen (PSA) Levels
Time frame · 6 and 12 months
Stable PSA level was noted as value either lower or less than 25% higher than the baseline value, or PSA value ≤0.5 ng/mL higher than the baseline value, if value ≥25% higher than the baseline value.
Change From Baseline in Quality of Life Using EuroQol 5 Dimensions 5 Levels [EQ-5D-5L] Questionnaire.
Time frame · Baseline and Month 12
The EQ-5D-5L questionnaire consisted of a description of raw data which comprised of five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension had five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The visual analogical scale of the EQ-5D-5L questionnaire was numbered from 0 to 100 (0 meaning the worst health the patient can imagine and 100 the best health the patient can imagine).
Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II)
Time frame · 6 and 12 month
TSQM comprised of four dimensions: effectiveness, side effects, convenience and overall global satisfaction. Each score ranged from 0 to 100. For effectiveness, convenience and overall global satisfaction scores, 0 indicated an extreme dissatisfaction and 100 indicated an extreme satisfaction. For side effects score, 0 indicated an extreme dissatisfaction and 100 indicated no dissatisfaction at all.
Patient Satisfaction With Treatment.
Time frame · Month 12
Using a non-validated study-specific descriptive Likert-type scale (with no units) comprising a simple six-question patient questionnaire.
Percentage of Participants Who Changed Injection Frequency After Completion of the Study
Time frame · Month 12
Eligibility
Inclusion Criteria: * Patients must give written (personally signed and dated) informed consent before completing any study related procedure. * Patients must be 18 years old or over. * Patients must have a documented diagnosis of locally advanced or metastatic prostate cancer suitable for hormonal treatment * Patients must be medically castrated with serum testosterone ≤ 0.5ng/mL * Patients must have received at least two injections of a 3- monthly LHRH agonist by the time of the screening tests * Patients must be stable on a 3-monthly LHRH agonist injection with stable PSA levels between screening and baseline (i.e. the baseline value must either be lower or less than 25% higher than the Screening value or if ≥25% higher, ≤0.5ng/mL higher than the screening value). In addition: * For patients with locally advanced prostate cancer (M0), LHRH agonist injection (any formulation) must have been initiated within the last 3 years from Baseline, * For patients with metastatic prostate cancer (M+) and a Gleason score ≤ 7, LHRH agonist injection (any formulation) must have been initiated within the last 2 years from Baseline, * For patients with metastatic prostate cancer (M+) and a Gleason score \> 7, LHRH agonist injection (any formulation) must have been initiated within the last 12 months from Baseline. * Patients must have an estimated life expectancy of at least twelve months according to the investigator's assessment. Exclusion Criteria: * Patients have had previous surgical castration or present any concomitant condition which could compromise the objectives of the study and/or preclude the protocol-defined procedures (e.g. severe medical conditions, brain metastases, psychiatric disorders, active or uncontrolled infection, known pituitary disease). * Patients are, in the opinion of the investigator, unable to comply fully with the protocol and the study instructions. * Patients have received investigational drug(s) or treatment(s) within 30 days prior to study entry or will require a concurrent treatment with any other experimental drugs or treatments or present any concomitant condition which could compromise the objectives of the study and/or preclude the protocol-defined procedures (e.g. severe medical conditions, brain metastases, psychiatric disorders, active or uncontrolled infection, known pituitary disease). * Patients have had a diagnosis of any other cancer without a history of stability/remission within five years of screening, with the exception of non-metastatic basal cell carcinoma. * Patients currently taking additional anti-androgen therapy as part of an active hormonal control therapy. * Patients scheduled to receive palliative radiotherapy during the course of the study. * Patients receiving an LHRH agonist as neo-adjuvant to radiotherapy or adjuvant to radiotherapy. * Patients receiving LHRH agonist as adjuvant to surgery. * Patients scheduled to undergo radical prostatectomy during the course of the study. * Patients with known hypersensitivity to LHRH agonists, their analogues or any or any other component of the products to be administered.
Study locations
United Kingdom. Showing up to 24 locations stored in the fast local snapshot.
The Crouch Oak Family Practice
Addlestone, United Kingdom
Dr Carter & Partners
Ashford, United Kingdom
Westongrove Research Centre, Aston Clinton Surgery
Aylesbury, United Kingdom
Clinical Research Unit, Oldfield Surgery
Bath, United Kingdom
Clinical Research Unit, The Pulteney Practice
Bath, United Kingdom
St James' Surgery
Bath, United Kingdom
Waterloo Medical Centre
Blackpool, United Kingdom
Woolpit Health Centre
Bury St Edmunds, United Kingdom
Cossington House Surgery
Canterbury, United Kingdom
Research Office, Avondale Surgery
Chesterfield, United Kingdom
Clinical Research Dept., Rowden Surgery
Chippenham, United Kingdom
Clinical Research Unit, Hathaway Medical Centre
Chippenham, United Kingdom
The Porch Surgery
Corsham, United Kingdom
Pound Hill Surgery
Crawley, United Kingdom
The Medical Centre
East Horsley, United Kingdom
Burbage Surgery
Hinckley, United Kingdom
The Portmill Surgery
Hitchin, United Kingdom
Townhead Surgery
Irvine, United Kingdom
Mortimer Surgery
Mortimer Common, United Kingdom
Kiltearn Medical Centre
Nantwich, United Kingdom
Danes Camp Surgery
Northampton, United Kingdom
Kingsthorpe Medical Centre
Northampton, United Kingdom
Cape Cornwall Surgery
Penzance, United Kingdom
The Alverton Practice
Penzance, United Kingdom
Publications
No PMID-linked publications were present in this registry snapshot.
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